IBC Training Course: Bioassay Method Development & Validation
IBC Training Course: Bioassay Method Development & Validation - Event details
10/16/2008
-
10/17/2008
RESEARCH TRIANGLE PARK
,
Raleigh
,
USA
(North Carolina)
Description
Bioassays are necessary components of the biopharmaceutical development process as functional potency assays during release, stability and formulation studies. The appropriate use of non-analytical techniques is also critical during PK/PD evaluation and in the measurement of systemic responses to drugs (i.e., immunogenicity). Furthermore, immunological and enzymatic methods are widely used in the detection of biological impurities due to their increased sensitivity and specificity over analytical methods (i.e., HPLC). The complexity of the materials and procedures involved in these technologies, however, result in significantly increased variability as compared to analytical methods. The lecture portion of this course outlines sensible approaches to develop reproducible bioassays using live systems and/or biologically derived reagents. These approaches are supplemented by guidelines to meet regulatory requirements according to their application. In addition, a workshop on writing validation protocols provides hands-on experience to cover these pivotal documents. You will also hear case studies that add relevance to the lecture materials and provide a launch point for class discussion.
Category
Biotechnology
More details (event webpage):
www.ibclifesciences.com
Apply for event:
Link
Event language:
English
Contact info:
IBC Customer Service
Phone:
+1 800 390-4078
Fax:
+1 941 365-0104
Email:
reg@ibcusa.com
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